Rapid exchange stent delivery system

ABSTRACT

Stent delivery systems and methods for making and using stent delivery systems are disclosed. An example stent delivery system may include a guide member having a proximal portion and a distal portion. A stent may be disposed about the distal portion of the guide member. The stent may have a wall having an opening formed therein. A pusher member may be disposed about the guide member and positioned proximal of the stent. A holding filament may be disposed at the opening and may extend to the proximal portion of the guide member. The holding filament may be configured to releasably secure the position of the stent relative to the pusher member. The holding filament may be releasable from the stent independently of movement of the guide member.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of U.S. application Ser. No.13/300,111, filed Nov. 18, 2011, which claims the benefit of U.S.Provisional Application No. 61/415,660, filed Nov. 19, 2010, the entiredisclosure of which is incorporated herein by reference.

FIELD OF THE INVENTION

The present invention pertains to medical devices and methods formanufacturing medical devices. More particularly, the present inventionpertains to medical devices for delivering stents to the biliary tractand/or the pancreatic tract.

BACKGROUND

A wide variety of intraluminal medical devices have been developed formedical use, for example, use in the biliary tract. Some of thesedevices include guidewires, catheters, stents, and the like. Thesedevices are manufactured by any one of a variety of differentmanufacturing methods and may be used according to any one of a varietyof methods. Of the known medical devices and methods, each has certainadvantages and disadvantages. There is an ongoing need to providealternative medical devices as well as alternative methods formanufacturing and using medical devices.

BRIEF SUMMARY

The invention provides design, material, manufacturing method, and usealternatives for medical devices or components thereof. An examplemedical device may be a stent delivery system that includes a guidemember having a proximal portion and a distal portion. A stent may bedisposed about the distal portion of the guide member. The stent mayhave a wall having an opening formed therein. A pusher member may bedisposed about the guide member and positioned proximal of the stent. Aholding filament may be disposed at the opening and may extend to theproximal portion of the guide member. The holding filament may beconfigured to releasably secure the position of the stent relative tothe pusher member. In addition, the holding filament may be releasablefrom the stent independently of movement of the guide member.

An example method for delivering a biliary or pancreatic stent mayinclude providing a stent delivery system. The stent delivery system mayinclude a guide member having a proximal portion and a distal portion. Astent may be disposed about the distal portion of the guide member. Thestent may have a wall having an opening formed therein. A pusher membermay be disposed about the guide member and positioned proximal of thestent. A filament may be disposed at the opening and may extend to theproximal portion of the guide member. The filament may be configured toreleasably secure the position of the stent relative to the pushermember. In addition, the filament may be releasable from the stentindependently of movement of the guide member. The method may alsoinclude advancing the stent delivery system along a body lumen to aposition adjacent to an area of interest and releasing the filament fromthe stent.

An example delivery system for delivering a biliary or pancreatic stentmay include a guide tube. A drainage stent may be disposed about theguide tube. The drainage stent may be tubular and may have a tube wallwith an opening formed therein. A push catheter may be disposed about aportion of the guide member proximal of the drainage stent. The deliverysystem may also include filament for securing the position of thedrainage stent relative to the push catheter. The stent may beconfigured to be in either a first configuration where the stent isreleasably secured relative to the push catheter with the filament or asecond configuration where the filament is released from the stent. Theguide tube may extend through the stent in both the first and secondconfigurations.

The above summary of some embodiments is not intended to describe eachdisclosed embodiment or every implementation of the present invention.The Figures and Detailed Description which follow more particularlyexemplify these embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention may be more completely understood in consideration of thefollowing detailed description of various embodiments of the inventionin connection with the accompanying drawings, in which:

FIG. 1 is a plan view of an example stent delivery system;

FIG. 2 is a longitudinal cross-sectional view of the stent deliverysystem illustrated in FIG. 1;

FIG. 3 illustrates an example arrangement for a holding filament thatmay be utilized with the stent delivery system illustrated in FIGS. 1-2;

FIG. 4 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 5 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 6 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 7 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 8 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 9 illustrates another example arrangement for a holding filamentthat may be utilized with the stent delivery system illustrated in FIGS.1-2;

FIG. 10 is a cross-sectional view of an example push catheter that maybe utilized with the stent delivery system illustrated in FIGS. 1-2;

FIG. 11 is a cross-sectional view of another example push catheter thatmay be utilized with the stent delivery system illustrated in FIGS. 1-2;

FIG. 12 is a cross-sectional view of another example push catheter thatmay be utilized with the stent delivery system illustrated in FIGS. 1-2;

FIG. 13 is a cross-sectional view of a portion of another example pushcatheter;

FIG. 14 is a cross-sectional view of a portion of another example pushcatheter;

FIG. 15 illustrates another example arrangement for a holding filamentthat may be utilized with a stent delivery system;

FIG. 16 illustrates another example arrangement for a holding filamentthat may be utilized with a stent delivery system;

FIG. 17 illustrates another example arrangement for a holding filamentthat may be utilized with a stent delivery system;

FIG. 18 is a plan view of an example arrangement for a holding filament;and

FIG. 19 is a plan view of another example arrangement for a holdingfilament.

While the invention is amenable to various modifications and alternativeforms, specifics thereof have been shown by way of example in thedrawings and will be described in detail. It should be understood,however, that the intention is not to limit the invention to theparticular embodiments described. On the contrary, the intention is tocover all modifications, equivalents, and alternatives falling withinthe spirit and scope of the invention.

DETAILED DESCRIPTION

For the following defined terms, these definitions shall be applied,unless a different definition is given in the claims or elsewhere inthis specification.

All numeric values are herein assumed to be modified by the term“about,” whether or not explicitly indicated. The term “about” generallyrefers to a range of numbers that one of skill in the art would considerequivalent to the recited value (i.e., having the same function orresult). In many instances, the terms “about” may include numbers thatare rounded to the nearest significant figure.

The recitation of numerical ranges by endpoints includes all numberswithin that range (e.g., 1 to 5 includes 1, 1.5, 2, 2.75, 3, 3.80, 4,and 5).

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” include plural referents unless the contentclearly dictates otherwise. As used in this specification and theappended claims, the term “or” is generally employed in its senseincluding “and/or” unless the content clearly dictates otherwise.

The following detailed description should be read with reference to thedrawings in which similar elements in different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

A wide variety of biliary, endoscopic, and/or endosurgical procedureshave been developed for making medical treatments, diagnoses, and imagesof areas along the biliary tract and/or the pancreatic tract. For thepurposes of this disclosure, the “biliary tract” and/or the “pancreatictract” are understood to include various components of the digestivesystem and include, for example, the various ducts of the biliary treebetween the liver and the duodenum as well as the various ducts betweenthe pancreas and the duodenum. Numerous endoscopic and/or endosurgicaldevices have been developed for making medical treatments, diagnoses,and images of areas along the biliary and pancreatic tracts. Some ofthese device and/or procedures include biliary catheters, biliaryguidewires, biliary stent delivery systems, and the like. In general,these devices are guided to the biliary and/or pancreatic tract by anendoscope (and/or a duodenoscope) that is disposed in the duodenum. Oncepositioned, various interventions can be performed depending on theneeds of the patient and the type of device utilized. Other locationsand/or uses are also contemplated for the systems disclosed hereinincluding, for example, urinary tract interventions and/or urologicalinterventions, gynecological interventions, etc.

When delivering a stent such as a drainage stent to the appropriateposition within the anatomy, it may be desirable to hold or secure theposition of the stent relative to a push catheter, which may be part ofthe stent delivery system. This allows the clinician to position anddeploy the stent accurately at the intended location. One way that thestent may be secured to the push catheter may be with the use of asuture. Conventionally when a suture is utilized to secure a stent to apush catheter, the suture is formed into a loop that is wrapped aroundthe guide catheter (which may extend through the lumen of the pushcatheter). The suture then extends through one of the barbed openings orflaps formed in the stent and it may be pulled snugly and attached ortied to the end of the push catheter, for example at a hole or openingformed at the distal end of the push catheter. As long as the positionof the guide catheter is held stationary relative to the push catheter,this arrangement holds the position of the stent and effectively securesthe stent to the push catheter. To release the stent, the guide cathetercan be proximally retracted to a point where it exits and is disposedproximally of the loop formed in the suture. When no longer wrappedaround the guide catheter, the loop or looped end of the suture is freeto simply exit the opening at the barbed flap of the stent such that thestent is released from the push catheter.

While effective, the above-described conventional use of a suture tosecure the stent relative to the push catheter is dependent on themanipulation of the guide catheter in order to deploy the stent.Furthermore, should the clinician desire to reposition the stent afterdeployment (e.g., due to improper or undesirable placement), additionalmanipulation steps may be required including further manipulation of theguide catheter.

Disclosed herein are a number of delivery systems for delivery a stent(e.g., a drainage stent) to an appropriate position within the anatomy.The delivery systems may use a holding filament or structure such as asuture to secure the position of the stent relative to a push member orcatheter. Deployment or release of the stent from the push catheter,however, can be accomplished independently of movement of the guidecatheter. Furthermore, the delivery systems disclosed herein may alsoallow the clinician to “resecure” the sent to the push catheter orotherwise allow for the clinician to reposition the stent, againindependently of movement of the guide catheter. Some additional detailsregarding these and other features of a number of different examplestent delivery systems are provided below.

Referring now to FIGS. 1 and 2, there is shown an example medicaldevice, illustrated as a delivery system 10 for delivering, for example,a stent 20 such as a drainage stent to a suitable target location suchas, for example, a target along the biliary and/or pancreatic tree. Thesystem 10 may also be used at any other suitable location. The stent 20may be used to bypass or drain an obstructed lumen, for example alongthe biliary and/or pancreatic tree, and can be configured for long-termpositioning within the body. It should be understood that the terms“drainage stent”, “drainage catheter” and “stent” can be usedinterchangeably with reference to the devices and systems disclosedherein.

The delivery system 10 may be designed for use with a conventionalguidewire 2 and may include a guide catheter 12, a push catheter 14, anda handle assembly 16. The guidewire 2 may extend into a lumen 22 of theguide catheter 12, through a distal guidewire port 24, and out aproximal guidewire port 26 formed in a sidewall of the push catheter 14,providing the delivery system 10 with single-operator-exchange (SOE)capabilities. Other embodiments are also contemplated, however, wherethe delivery system 10 is an over-the-wire (OTW) system.

The guide catheter 12 may be slidably disposed within the lumen 28 ofthe push catheter 14 and may extend distally from the distal end of thepush catheter 14. The stent 20 may be positioned on a distal portion ofthe guide catheter 12, which may be located distal of the push catheter14, and the stent 20 may abut the distal end 30 of the push catheter 14.The system 10 may also include a holding filament or suture 44 forreleasably connecting the push catheter 14 to the stent 20. Someadditional details regarding the holding filament 44 and/or theconnection of the stent 20 with the push catheter 14 (and/or otherstructures of the system 10) are provided below. When the stent 20 hasbeen properly placed, the stent 20 may be disconnected from the pushcatheter 14 such that the stent 20 remains in the anatomy or body lumenwhen the push catheter 14 is withdrawn.

The proximal end 32 of the push catheter 14 may be attached to thehandle assembly 16. For example, the proximal end 32 may include afemale luer lock connector 34 threadably coupled to a threaded maleconnector 36 of the handle assembly 16. It may be understood, however,that the push catheter 14 may be attached to the handle assembly 16 andextend distally therefrom by other means, such as adhesive bonding,welding, friction fit, interlocking fit, or other suitable means.

The guide catheter 12 may include a distal tubular portion 38 and aproximal elongate wire 40, such as a pull wire, coupled to the distaltubular portion 38. In some instances, the elongate wire 40 may be awire, filament, thread, portion of a catheter wall, fabric, web, orsimilar elongate structure. The elongate wire 40 may be coupled to thedistal tubular portion 38 at a rotatable connection that may allowrotatable movement between the tubular portion 38 and the elongate wire40 of the guide catheter 12. The elongate wire 40 may extend through thelumen 28 of the push catheter 14 to the handle assembly 16. In someembodiments, the elongate wire 40 may extend through the handle assembly16 to a location proximal of the handle assembly 16. The proximal end ofelongate wire 40 may terminate at a knob 42 which may be grasped by anoperator to manipulate the guide catheter 12.

As shown in FIG. 2, the elongate wire 40 may share the lumen 28 of thepush catheter 14 with the guidewire 2 along a portion of the length ofthe elongate wire 40. Thus, a portion of the elongate wire 40 may extendproximally from the tubular portion 38 along the side of the guidewire 2through the lumen 28 of the push catheter 14 up to a location where theguidewire 2 exits the proximal guidewire port 26 of the push catheter14.

As indicated above, the holding filament 44 may secure the stent 20 tothe push member. In at least some embodiments, the holding filament 44is a suture. However, this is not intended to be limiting as the holdingfilament 44 may take the form of any suitable structure such as a wire,cord, braid, coil, or the like. Indeed, the holding filament 44 may be amono-filament structure (e.g., made from a singular filament) ormulti-filament structure (e.g., made from a plurality of filaments thatmay or may not be the same). The holding filament may be made from anysuitable material including polymers, natural materials, metals, catgut,cotton, and the like, combinations thereof, or any other suitablematerial including those materials disclosed herein. In someembodiments, more than one holding filaments 44 may be utilized. Itshould be understood that the terms “holding filament” and “suture” canbe used interchangeably with reference to the devices and systemsdisclosed herein.

The stent 20 may include one or more anchors 46 that are generallydisposed near an opening 50 in the stent 20. Anchors 46, for example,may project radially outward from the stent 20 and help to secure or“anchor” the position of the stent 20 within the anatomy when deployed.In at least some embodiments, the anchors 46 are defined by a skived cutin the stent 20 and take the form of a barb or barb-like flap. Otherconfigurations are contemplated.

In at least some embodiments, the suture 44 may wrap around the anchor46. Such a configuration may also be described as the suture 44 beingdisposed in the opening 50, at the opening 50, or adjacent the opening50 of the stent 20. The suture 44, rather than being tied to the pushcatheter 14, may extend proximally along the push catheter 14 to aposition adjacent the handle assembly 16. For example, the suture 44 mayextend to a control or actuation member, shown generally at referencenumber 48. In other embodiments, the ends of the suture 44 may extendback toward the handle assembly 16 and be accessible to the user suchthat the control 48 is optional or may be omitted. In general, thesuture 44 may be free of attachment or securement to the push catheter14.

The control 48, which may or may not be secured to the handle assembly16, may allow the clinician to manipulate and/or alter the attachment ofthe stent 20 to the push catheter 14. For example, the control 48 mayallow the user to release one end of the suture 44 (e.g., when thesuture is formed as a loop so that two ends extend to the control 48)and pull the other end so that the suture 44 is proximally retracteduntil the suture 44 is no longer wrapped around the anchor 46. Thisessentially “frees” the stent 20 from the pusher member 14. If thecontrol 48 is not being utilized, the same thing can be accomplished bythe user releasing one of the ends of the suture 44 and proximallyretracting the other end until the suture 44 is no longer wrapped aroundthe anchor 46. In other embodiments, the user may actuate the control 48or otherwise pull on the suture such that sufficient force is generatedto sever the suture 44 (e.g., break, cut, or otherwise becomedissociated with the anchor 46) and effect release of the stent 20. Forexample, the suture 44 may be predisposed to break at a predeterminedforce by altering the suture by thinning (e.g., in diameter) a portionthereof, by omitting structure that might otherwise strengthen orsupport the suture (e.g., braids, etc.), notching, making the suture 44brittle (e.g., brittle at a pre-determined location), etc. Otherconfigurations are contemplated for releasing the stent 20 from thepusher member 14.

In addition to being configured to release the stent 20 from the pushermember 14 and/or to deploy the stent 20, the holding filament/suture 44may also be used to reposition the stent 20. For example, the suture 44may be partially actuated. For the purposes of this disclosure,partially actuating the suture 44 may be understood to be “loosening” orotherwise be manipulating the suture 44 so as to create enough slacktherein that the pusher member 14 can be moved a relatively shortdistance away from to the stent 20. This may allow the stent 20 to atleast partially deploy or be placed within the anatomy. The user maythen observe or visualize the position of the stent 20. If the userdecides that the position of the stent 20 needs to be altered, the slackin the suture 20 can be removed (e.g., the suture 20 can be “tightened”)so that the stent 20 once again become secured to the pusher member 14and the stent 20 can be repositioned (e.g., urged distally and/orproximally, as desired). Once the user is satisfied with the position ofthe stent 20, the suture 44 can be “fully actuated” (e.g., in one of themanners disclosed herein or any other suitable manner) so that the stent20 is deployed and the delivery device 10 can be removed from theanatomy.

FIG. 3 illustrates another example arrangement for the suture 44 thatmay be utilized with the delivery device 10. In this embodiment, thesuture 44 be wrapped around the anchor 46 and be tied into a knot 52.According to this embodiment, only a singular “end” of the suture 44(rather than two opposite ends) may extend to the control 48 orotherwise be accessible to the user. To release the stent 20, sufficientforce may be exerted onto suture 44 so as to sever the suture 44 (e.g.,at or adjacent the knot 52) and release the stent 20. Alternatively, theknot 52 may be a slip-type knot so that the knot 52 can be untied bypulling on the end of the suture 44. In still other embodiments, asecondary suture (not shown) may be coupled to the knot 52 and, forexample, extend proximally to the handle assembly 16. The secondarysuture may be actuated to release the knot 52. Numerous otherconfigurations are contemplated.

FIGS. 4-5 illustrates additional example arrangements for the suture 44that may be utilized with the delivery device 10. In the embodimentillustrated in FIG. 4, the suture 44 again wraps around the anchor 46.However, instead of being disposed along the exterior of the pushcatheter 14, for example as shown in FIGS. 1-3, the suture 44 extendsalong the interior of the push catheter 14, for example through thelumen 28 of the push catheter 14 or otherwise between the push catheter14 and the guide catheter 12. In the embodiment illustrated in FIG. 5,the suture 44 may extend through the opening 50 in the stent 22 and tiedinto a knot 52, and the singular end may extend proximally through thelumen 28 of the push catheter 14 or otherwise between the push catheter14 and the guide catheter 12.

Other embodiments are also contemplated where the suture 44 may extendthrough the opening 50 of the stent 20. According to these embodiments,one end of the suture 44 may extend along the exterior of the pushcatheter 14. The other end of the suture 44 may extend along theinterior of the push catheter 14 or the other end of the suture 44 mayfollow the interior of the stent 20, extend between the proximal end ofthe stent 20 and the distal end 30 of the push catheter 14, and thenextend along the exterior of the push catheter 14. Alternatively, oneend of the suture 44 may extend along the interior of the push catheter14 and the other end of the suture 44 may either extend along theinterior of the push catheter 14 or it may follow the exterior of thestent 20, extend between the proximal end of the stent 20 and the distalend 30 of the push catheter 14, and then extend along the interior ofthe push catheter 14.

FIG. 6-7 illustrate additional example arrangements for the suture 44that may be utilized with the delivery device 10. In the embodimentillustrated in FIG. 6, the stent 120 has an opening 151 formed therein.The opening 151 is different from the opening 150 formed at the anchor146. For example, the opening 151 may be positioned adjacent to theanchor 146, proximal of the anchor 146, or at any other suitablelocation. Indeed, in some embodiment, the stent 120 may not have anopening at the anchor 146. This may be true in this or any otherembodiment disclosed herein. The suture 44 may be looped through theopening 151 and then the suture 44 may along the exterior of the pushcatheter 14, for example, to the control 48. In the embodimentillustrated in FIG. 7, the suture 44 may be looped through the opening151 and tied into a knot 52. The end of the suture 44 may extend alongthe exterior of the push catheter 14 to the control 48.

FIGS. 8-9 illustrates additional example arrangements for the suture 44that may be utilized with the delivery device 10. In the embodimentillustrated in FIG. 8, the suture 44 is again looped through the opening151 in the stent 120 and then extends along the interior of the pushcatheter 14, for example through the lumen 28 of the push catheter 14 orotherwise between the push catheter 14 and the guide catheter 12. In theembodiment illustrated in FIG. 9, the suture 44 is again looped throughthe opening 151 in the stent 120 and tied into a knot 52 and thesingular end extends along the interior of the push catheter 14, forexample through the lumen 28 of the push catheter 14 or otherwisebetween the push catheter 14 and the guide catheter 12.

FIGS. 10-12 illustrates alternative example push catheters that may beutilized with the delivery system 10. In general, these push cathetershave one or more openings or lumens formed in the wall of the pushcatheter. The suture 44 may pass through the lumen(s) to a positionadjacent the handle assembly 16 so that the suture 44 may be associatedwith the control 48 or otherwise accessible to the user. The use of suchpush catheters having one or more lumens in the wall may be desirablefor a number of reasons. For example, the use of push catheters havingone or more lumens in the wall may allow the suture 44 to extendproximally back toward the handle assembly 16 without being eitherexposed to either the exterior of the push catheter 14 or the interiorthe push catheter 14 (e.g., between the push catheter 14 and the guidecatheter 12) where the suture 44 could get caught on, break, orotherwise disrupt other structures of the delivery system 10 and/orinterrupt proper delivery of the stent (e.g., the stent 20/120).

FIG. 10 illustrates the push catheter 214 having a single opening orlumen 254 formed in the wall 256 thereof. In embodiments such as thoseshown in FIGS. 1-2, 4, 6, and 8, where the two opposite ends of thesuture 44 may extend back toward the handle assembly 16, the singlelumen 254 allows both ends of the suture 44 (which are shown in FIG. 10and bear reference numbers 44 a/44 b) to extend proximally through asingular channel. In embodiments such as those shown in FIGS. 3, 5, 7,and 9, where the suture 44 is tied into a knot 52 and a singular “end”extends back toward the handle assembly 16, the single lumen 254 mayallow this singular end of the suture to extend proximally toward thehandle assembly as shown in FIG. 11. In the embodiment shown in FIG. 12,a pair of lumens 354 a/354 b are formed in the wall of the push catheter314. According to this embodiment, each of the ends 44 a/44 b of thesuture 44 can extend through its own lumen 354 a/354 b.

FIGS. 13-14 illustrate additional contemplated push catheters. Forexample, FIG. 13 illustrates the push catheter 414 having a groove 458.In this embodiment, the groove 458 is formed in the outer surface of thepush catheter 414. The groove 458 may act as a guide for the suture orholding filament. The groove 458 may extend along one or more discreteportions of the length of the push catheter 414 or along essentially thefull length thereof. Similarly, FIG. 14 illustrates the push catheter514 with a groove 558 formed along an inner surface. Just like groove458, groove 558 may extend along one or more discrete portions of thelength of the push catheter 514 or along essentially the full lengththereof. Either or both of the grooves 458/558 may be utilized in any ofthe embodiments disclosed herein.

FIGS. 15-19 illustrate additional example arrangements for a holdingfilament that may be utilized with a stent delivery system including anyof those disclosed herein. For example, in FIG. 15 the holding filament644 includes a first portion 660, which may take the form of a loopedwire, and a second portion 661, which may also take the form of a loopedwire. The portions 660/661 may loop or otherwise intersect with oneanother at an intersection 662 and they may extent around the anchor 46.Similarly, in FIG. 16 the holding filament 744 includes a first portion760 taking the form of a loop and a second portion 761 taking the formof a single filament. The portions 760/761 may be joined at a knot 752and they may extend around the anchor 46. Finally, as shown in FIG. 17the holding filament 844 may include a first portion 860 taking the formof a single filament tied with a knot 852 a to form a loop and a secondportion 861 also taking the form of a single filament tied with a knot852 b to form a loop. The loops may join together at an intersection 862and the portions 860/861 may extend around the anchor 46. Any of theholding filaments and/or arrangements of holding filaments may beutilized with any of the systems disclosed herein.

FIGS. 18-19 illustrate additional holding filament arrangements that mayalso be used with any of the systems disclosed herein. For example, oneexample holding filament 944, as shown in FIG. 18, may include a firstportion 944 a and a second portion 944 b joined together with a bond952. In some embodiments, the bond 952 may be an adhesive. Other bondsmay also be utilized. Similarly, FIG. 19 illustrates another exampleholding filament 1044 that includes a first looped portion 1044 a and asecond looped portion 1044 b joined together with a bond 1052. The bond1052, just like the bond 952, may include adhesive or any other suitablebonding material.

The materials that can be used for the various components of thedelivery system 10 may include those commonly associated with medicaldevices. For simplicity purposes, the following discussion makesreference to the push catheter 14. However, this is not intended tolimit the devices and methods described herein, as the discussion may beapplied to any of the other structures and/or components of the deliverydevices disclosed herein.

The push catheter 14 and/or other components of the delivery device 10may be made from a metal, metal alloy, polymer (some examples of whichare disclosed below), a metal-polymer composite, ceramics, combinationsthereof, and the like, or other suitable material. Some examples ofsuitable metals and metal alloys include stainless steel, such as 304V,304L, and 316LV stainless steel; mild steel; nickel-titanium alloy suchas linear-elastic and/or super-elastic nitinol; other nickel alloys suchas nickel-chromium-molybdenum alloys (e.g., UNS: N06625 such as INCONEL®625, UNS: N06022 such as HASTELLOY® C-22®, UNS: N10276 such asHASTELLOY® C276®, other HASTELLOY® alloys, and the like), nickel-copperalloys (e.g., UNS: N04400 such as MONEL® 400, NICKELVAC® 400, NICORROS®400, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g., UNS:R30035 such as MP35-N® and the like), nickel-molybdenum alloys (e.g.,UNS: N10665 such as HASTELLOY® ALLOY B2®), other nickel-chromium alloys,other nickel-molybdenum alloys, other nickel-cobalt alloys, othernickel-iron alloys, other nickel-copper alloys, other nickel-tungsten ortungsten alloys, and the like; cobalt-chromium alloys;cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like); platinum enriched stainless steel; titanium;combinations thereof; and the like; or any other suitable material.

As alluded to herein, within the family of commercially availablenickel-titanium or nitinol alloys, is a category designated “linearelastic” or “non-super-elastic” which, although may be similar inchemistry to conventional shape memory and super elastic varieties, mayexhibit distinct and useful mechanical properties. Linear elastic and/ornon-super-elastic nitinol may be distinguished from super elasticnitinol in that the linear elastic and/or non-super-elastic nitinol doesnot display a substantial “superelastic plateau” or “flag region” in itsstress/strain curve like super elastic nitinol does. Instead, in thelinear elastic and/or non-super-elastic nitinol, as recoverable strainincreases, the stress continues to increase in a substantially linear,or a somewhat, but not necessarily entirely linear relationship untilplastic deformation begins or at least in a relationship that is morelinear that the super elastic plateau and/or flag region that may beseen with super elastic nitinol. Thus, for the purposes of thisdisclosure linear elastic and/or non-super-elastic nitinol may also betermed “substantially” linear elastic and/or non-super-elastic nitinol.

In some cases, linear elastic and/or non-super-elastic nitinol may alsobe distinguishable from super elastic nitinol in that linear elasticand/or non-super-elastic nitinol may accept up to about 2-5% strainwhile remaining substantially elastic (e.g., before plasticallydeforming) whereas super elastic nitinol may accept up to about 8%strain before plastically deforming. Both of these materials can bedistinguished from other linear elastic materials such as stainlesssteel (that can also can be distinguished based on its composition),which may accept only about 0.2 to 0.44 percent strain beforeplastically deforming.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy is an alloy that does not show anymartensite/austenite phase changes that are detectable by differentialscanning calorimetry (DSC) and dynamic metal thermal analysis (DMTA)analysis over a large temperature range. For example, in someembodiments, there may be no martensite/austenite phase changesdetectable by DSC and DMTA analysis in the range of about −60 degreesCelsius (° C.) to about 120° C. in the linear elastic and/ornon-super-elastic nickel-titanium alloy. The mechanical bendingproperties of such material may therefore be generally inert to theeffect of temperature over this very broad range of temperature. In someembodiments, the mechanical bending properties of the linear elasticand/or non-super-elastic nickel-titanium alloy at ambient or roomtemperature are substantially the same as the mechanical properties atbody temperature, for example, in that they do not display asuper-elastic plateau and/or flag region. In other words, across a broadtemperature range, the linear elastic and/or non-super-elasticnickel-titanium alloy maintains its linear elastic and/ornon-super-elastic characteristics and/or properties.

In some embodiments, the linear elastic and/or non-super-elasticnickel-titanium alloy may be in the range of about 50 to about 60 weightpercent nickel, with the remainder being essentially titanium. In someembodiments, the composition is in the range of about 54 to about 57weight percent nickel. One example of a suitable nickel-titanium alloyis FHP-NT alloy commercially available from Furukawa Techno Material Co.of Kanagawa, Japan. Some examples of nickel titanium alloys aredisclosed in U.S. Pat. Nos. 5,238,004 and 6,508,803, which areincorporated herein by reference. Other suitable materials may includeULTANIUM™ (available from Neo-Metrics) and GUM METAL™ (available fromToyota). In some other embodiments, a superelastic alloy, for example asuperelastic nitinol can be used to achieve desired properties.

In at least some embodiments, portions or all of the push catheter 14and/or other components of the delivery device 10 may also be dopedwith, made of, or otherwise include a radiopaque material. Radiopaquematerials are understood to be materials capable of producing arelatively bright image on a fluoroscopy screen or another imagingtechnique during a medical procedure. This relatively bright image aidsthe user of the delivery device 10 in determining its location. Someexamples of radiopaque materials can include, but are not limited to,gold, platinum, palladium, tantalum, tungsten alloy, polymer materialloaded with a radiopaque filler, and the like. Additionally, otherradiopaque marker bands and/or coils may also be incorporated into thedesign of the delivery device 10 to achieve the same result.

In some embodiments, a degree of Magnetic Resonance Imaging (MRI)compatibility is imparted into the delivery device 10. For example, toenhance compatibility with MRI machines, it may be desirable to make thepush catheter 14, or other portions of the delivery device 10, in amanner that would impart a degree of MRI compatibility. For example, thepush catheter 14, or portions thereof, may be made of a material thatdoes not substantially distort the image and create substantialartifacts (i.e., gaps in the image). Certain ferromagnetic materials,for example, may not be suitable because they may create artifacts in anMM image. The push catheter 14, or portions thereof, may also be madefrom a material that the MM machine can image. Some materials thatexhibit these characteristics include, for example, tungsten,cobalt-chromium-molybdenum alloys (e.g., UNS: R30003 such as ELGILOY®,PHYNOX®, and the like), nickel-cobalt-chromium-molybdenum alloys (e.g.,UNS: R30035 such as MP35-N® and the like), nitinol, and the like, andothers.

The push catheter 14 and/or other component the delivery system 10 maybe made from or otherwise include a polymer or polymeric material. Someexamples of suitable polymers may include polytetrafluoroethylene(PTFE), ethylene tetrafluoroethylene (ETFE), fluorinated ethylenepropylene (FEP), polyoxymethylene (POM, for example, DELRIN® availablefrom DuPont), polyether block ester, polyurethane (for example,Polyurethane 85A), polypropylene (PP), polyvinylchloride (PVC),polyether-ester (for example, ARNITEL® available from DSM EngineeringPlastics), ether or ester based copolymers (for example,butylene/poly(alkylene ether) phthalate and/or other polyesterelastomers such as HYTREL® available from DuPont), polyamide (forexample, DURETHAN® available from Bayer or CRISTAMID® available from ElfAtochem), elastomeric polyamides, block polyamide/ethers, polyetherblock amide (PEBA, for example available under the trade name PEBAX®),ethylene vinyl acetate copolymers (EVA), silicones, polyethylene (PE),Marlex high-density polyethylene, Marlex low-density polyethylene,linear low density polyethylene (for example REXELL®), polyester,polybutylene terephthalate (PBT), polyethylene terephthalate (PET),polytrimethylene terephthalate, polyethylene naphthalate (PEN),polyetheretherketone (PEEK), polyimide (PI), polyetherimide (PEI),polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polyparaphenylene terephthalamide (for example, KEVLAR®), polysulfone,nylon, nylon-12 (such as GRILAMID® available from EMS American Grilon),perfluoro(propyl vinyl ether) (PFA), ethylene vinyl alcohol, polyolefin,polystyrene, epoxy, polyvinylidene chloride (PVdC),poly(styrene-b-isobutylene-b-styrene) (for example, SIBS and/or SIBS50A), polycarbonates, ionomers, biocompatible polymers, other suitablematerials, or mixtures, combinations, copolymers thereof, polymer/metalcomposites, and the like. In some embodiments the polymer can be blendedwith a liquid crystal polymer (LCP). For example, the mixture cancontain up to about 6 percent LCP.

In some embodiments, the exterior surface of the delivery device 10 maybe sandblasted, beadblasted, sodium bicarbonate-blasted,electropolished, etc. In these as well as in some other embodiments, acoating, for example a lubricious, a hydrophilic, a protective, or othertype of coating may be applied over portions or all of the deliverydevice 10. Hydrophobic coatings such as fluoropolymers provide a drylubricity which improves guidewire handling and device exchanges.Lubricious coatings improve steerability and improve lesion crossingcapability. Suitable lubricious polymers are well known in the art andmay include silicone and the like, hydrophilic polymers such ashigh-density polyethylene (HDPE), polytetrafluoroethylene (PTFE),polyarylene oxides, polyvinylpyrolidones, polyvinylalcohols, hydroxyalkyl cellulosics, algins, saccharides, caprolactones, and the like, andmixtures and combinations thereof. Hydrophilic polymers may be blendedamong themselves or with formulated amounts of water insoluble compounds(including some polymers) to yield coatings with suitable lubricity,bonding, and solubility. Some other examples of such coatings andmaterials and methods used to create such coatings can be found in U.S.Pat. Nos. 6,139,510 and 5,772,609, which are incorporated herein byreference.

The coating and/or sheath may be formed, for example, by coating,extrusion, co-extrusion, interrupted layer co-extrusion (ILC), or fusingseveral segments end-to-end. The layer may have a uniform stiffness or agradual reduction in stiffness from the proximal end to the distal endthereof. The gradual reduction in stiffness may be continuous as by ILCor may be stepped as by fusing together separate extruded tubularsegments. The outer layer may be impregnated with a radiopaque fillermaterial to facilitate radiographic visualization. Those skilled in theart will recognize that these materials can vary widely withoutdeviating from the scope of the present invention.

The arrangement of the various structures of the delivery system 10 mayvary. In some embodiments, the system 10 may include any of thestructures or utilize any of the arrangements of structures that aredisclosed in U.S. Pat. Nos. 5,152,749; 5,334,185; 5,921,952; 6,248,100;6,264,624; and 6,562,024, the entire disclosures of which are hereinincorporated by reference.

It should be understood that this disclosure is, in many respects, onlyillustrative. Changes may be made in details, particularly in matters ofshape, size, and arrangement of steps without exceeding the scope of theinvention. The invention's scope is, of course, defined in the languagein which the appended claims are expressed.

What is claimed is:
 1. A stent delivery system, comprising: a guidemember having a proximal portion and a distal portion; a stent disposedabout the distal portion of the guide member, wherein the stent has awall having an opening formed therein; a pusher member disposed aboutthe guide member and positioned proximal of the stent; wherein thepusher member is designed to abut a proximal end of the stent; a holdingfilament disposed adjacent the opening and extending to the proximalportion of the guide member, wherein the holding filament includes afirst filament portion, a second filament portion and a loop portionextending between the first filament portion and the second filamentportion, wherein the loop portion of the holding filament is configuredto releasably secure the position of the stent relative to the pushermember, and wherein the holding filament can be released from the stentindependently of movement of the guide member; wherein the pusher memberincludes a longitudinal axis and defines a central lumen, wherein thecentral lumen has a tube wall having a proximal end and a distal end;wherein the pusher member has an exterior surface that includes a grooveformed along at least a portion thereof; and wherein the first andsecond filament portions extend along the groove.
 2. The stent deliverysystem of claim 1, wherein the stent is configured to be in either afirst configuration or a second configuration where the stent isreleasably secured relative to the pusher member with the holdingfilament and a second configuration where the holding filament isreleased from the stent.
 3. The stent delivery system of claim 2,wherein the guide member extends through the stent in both the first andsecond configurations.
 4. The stent delivery system of claim 1, whereinthe holding filament is actuatable from a control disposed at theproximal portion of the guide member.
 5. The stent delivery system ofclaim 1, wherein the holding filament includes a knot that can be untiedwhen the holding filament is pulled.
 6. The stent delivery system ofclaim 1, wherein the holding filament includes a first portion and asecond portion joined together with an adhesive bond.
 7. The stentdelivery system of claim 1, wherein the holding filament is predisposedto break.
 8. The stent delivery system of claim 1, wherein the stentincludes an anchor.
 9. The stent delivery system of claim 8, wherein theholding filament is wrapped around the anchor.
 10. The stent deliverysystem of claim 8, wherein the opening formed in the stent is positionedadjacent to the anchor and the suture extends through the opening.
 11. Astent delivery system, comprising: a guide member having a proximalportion and a distal portion; a stent disposed about the distal portionof the guide member, wherein the stent has a wall having an openingformed therein; a pusher member disposed about the guide member andpositioned proximal of the stent; and a holding filament disposedadjacent the opening and extending to the proximal portion of the guidemember, wherein the holding filament includes a first filament portion,a second filament portion and a loop portion extending between the firstfilament portion and the second filament portion, wherein the loopportion is configured to releasably secure the position of the stentrelative to the pusher member, and wherein the holding filament can bereleased from the stent independently of movement of the guide member;wherein the pusher member has a tube wall having a proximal end and adistal end; wherein the pusher member has a pair of lumens defined inthe tube wall that extends between the proximal end and the distal end;and wherein at least a portion of the first filament portion extendsthrough one of the lumens and at least a portion of the second filamentportion extends through another of the lumens.
 12. The stent deliverysystem of claim 11, wherein the stent is configured to be in either afirst configuration where the stent is releasably secured relative tothe pusher member with the holding filament and a second configurationwhere the holding filament is released from the stent.
 13. The stentdelivery system of claim 12, wherein the guide member extends throughthe stent in both the first and second configurations.
 14. The stentdelivery system of claim 11, wherein the holding filament is actuatablefrom a control disposed at the proximal portion of the guide member. 15.The stent delivery system of claim 11, wherein the holding filamentincludes a knot that can be untied when the holding filament is pulled.16. The stent delivery system of claim 11, wherein first and secondfilament portions are joined together with an adhesive bond.
 17. Thestent delivery system of claim 11, wherein the holding filament ispredisposed to break.
 18. The stent delivery system of claim 11, whereinthe stent includes an anchor and wherein the holding filament is wrappedaround the anchor.
 19. The stent delivery system of claim 11, whereinthe stent includes an anchor, wherein the opening formed in the stent ispositioned proximal to the anchor, and wherein the suture extendsthrough the opening.
 20. The stent delivery system of claim 11, whereinthe pusher member has an exterior surface and wherein the holdingfilament extends along at least a portion of the exterior surface.